NCPA Advocacy Update

Week ending June 22

Author: APCI Staff/Monday, June 25, 2018/Categories: Legislative Affairs

NCPA member RFI comment template now available

NCPA has developed template comments that individual pharmacists can personalize and submit to the docket pertaining to the Trump administration’s proposed blueprint/RFI for lowering drug prices and out of pocket costs.

The comments track closely to NCPA’s asks on the RFI, which can be viewed here, and request the final plan that emerges:

  • Eliminate pharmacy DIR in the Medicare Part D program. In light of the President’s Blueprint and the Department of Health and Human Services RFI language to prohibit pharmacy benefit managers (PBMs) from using rebates in contracts with manufacturers, NCPA is advocating that the administration extend this policy to pharmacy and eliminate pharmacy direct and indirect remuneration (DIR) fees in the Medicare Part D program entirely.
  • Eradicate PBM hidden spread amounts by requiring fiduciary status for PBMs. NCPA urges the administration to require PBMs to have a fiduciary duty to the entity for whom they manage pharmaceutical benefits, a move that would shed light on opaque PBM practices, including the PBM’s incentive to charge the plan more than the pharmacy is reimbursed, and keeping the difference as profit.

Please take a moment to submit comments and personalize to include your own experiences.


Progress on House and Senate opioid legislation

This week, the House completed its consideration of legislation to address the opioid crisis. In total, the House has passed more than 50 individual bills that will be packaged together in one legislative vehicle. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, will serve as the underlying vehicle for the majority of House-passed bills to combat the opioid crisis to move over to the Senate. While the relevant Senate committees have marked up opioid legislation, it remains to be seen when the Senate will take up their bills.


FDA listening session on compounding

FDA held a listening session on Tuesday to hear from stakeholders on compounding issues. NCPA was invited to attend on a panel of pharmacy stakeholders. NCPA was represented by AJ Day of PCCA, who serves on NCPA’s Compounding Committee, and Adam Harbison, NCPA Director of Congressional Affairs. Topics discussed at the listening session included the revisions FDA is undertaking to its Memorandum of Understanding, its guidance on the use of bulk substances by 503B outsourcing facilities, and continued access problems for office use compounds because of the agency’s prescription requirement.


Senate HELP Committee hearing on 340B program

On Tuesday, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, “Effective Administration of the 340B Drug Pricing Program,” to discuss Health Resources and Services Administration (HRSA) implementation and oversight of the 340B program. Chairman Lamar Alexander (R-Tenn.) chaired the hearing, emphasizing Congress needs more data to consider potential changes to improve the program. He also expressed concern over the lack of information regarding how covered entities use savings from 340B drug discounts. The Chairman suggested the need for covered entity reporting without creation of restrictive regulations on use of discounts. Senator Bill Cassidy, M.D. (R-La.), serving as chair for part of the hearing, emphasized the program creates incentives for hospitals to over-prescribe 340B covered drugs, and results in cost shifting to other payers. In contrast, Ranking Member Patty Murray (D-Wash.) and Democratic Members, including Senator Elizabeth Warren (D-Mass.), sharply criticized the Administration’s implementation of the program, including delay of the ceiling price and civil monetary penalties final rule, and called for greater oversight of manufacturer compliance with program requirements.


Senate Finance Committee to hold hearing
on prescription drug affordability

The Senate Committee on Finance is scheduled to hold a hearing next week on prescription drug affordability and innovation. HHS Secretary Azar will be providing testimony at the hearing. NCPA will be submitting a statement for the record and will be in attendance at the hearing.


President releases proposed government reorganization plan

The White House released its government reorganization plan this week, a part of which includes renaming and reshaping the Department of Health and Human Services and changing aspects of the FDA, NIH, and U.S. Public Health Service Commissioned Corps. It is unlikely that many of these proposals will take place as much of the plan would require approval from Congress before the changes could take place. A copy of the proposed reorganization is available here.


NCPA presents at American Society for Automated Pharmacy

This week, Kala Shankle, NCPA director of policy and regulatory affairs, presented at the American Society for Automated Pharmacy. The presentation focused on community pharmacists’ concerns and questions regarding DSCSA and value-adds that technology vendors and solutions providers could develop to help the community pharmacy industry comply with current and future aspects of the law.


MACPAC releases June report to Congress

The Medicaid and CHIP Payment and Access Commission, or MACPAC, released its June 2018 report to Congress. The report addresses the Medicaid drug rebate program, opioid epidemic, and long-term services and supports in Medicaid programs, and it provides recommendations for changes to federal statutory provisions related to these areas. The report is available here.


NCPA advocacy update to Value Drug Company
Regional Advisor Committee

This week, Allie Jo Shipman, NCPA associate director of state government affairs, provided an update on NCPA’s advocacy efforts to the Value Drug Company Regional Advisor Committee at the Value Merchandise Expo in Duncansville, Pa. The update provided information on NCPA’s activity around the President’s blueprint and HHS request for information, as well as an overview of state legislative wins this session.


Pennsylvania bill passes House in unanimous vote

Pennsylvania House Bill 2212, which would provide for financial disclosures by PBMs related to pharmacy services, passed the House unanimously this week and will move on to the Senate.


NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC.

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